Efficacy and Safety of Sotalol in Children With Arrhythmia

Arrhythmia Clinical Trial

Official title:

Multicenter Clinical Study of Therapeutic Effect of Sotalol on Children With Arrhythmia (Paroxysmal Supraventricular Tachycardia, Paroxysmal Atrial Tachycardia, Ventricular Tachycardia, Idiopathic Ventricular Tachycardia, Premature Ventricular Contraction ) in Children Aged From 0d to 14 Yrs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03895411
• Other study ID #: SJEX001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2019
• Est. completion date: December 2022

Study information

• Verified date: March 2019
• Source: Shengjing Hospital
• Contact: Hong Wang, MD
• Phone: 86-18940251677
• Email: wanghong_64[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the efficacy and safety of oral sotalol alone or combination with other anti-arrhythmic medicines in the treatment of arrhythmias in children. The study will regularly monitor the Holter, electrocardiogram (ECG), Echocardiography (Echo), blood routine, urine routine, serum ion, liver and kidney function, troponin I, hypersensitive troponin T, N-terminal pro-brain natriuretic peptide (NT pro-BNP), etc, before and after receive sotalol therapy. Compare the degree of arrhythmia improvement in patients and the side effects after oral sotalol.

Description:

Monitoring the Holter, ECG, Echocardiography , blood routine, urine routine, serum ion, liver and kidney function, troponin I, hypersensitive troponin T, NT pro-BNP beforehand. Eligible patients should stop all anti-arrhythmia drugs and digitalis, tricyclic antidepressants, beta blockers or calcium antagonists for at least 5 half-lives, and then do Holter. Randomly grouped. Judging the results according to the situation before and after oral sotalol.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

Inclusion Criteria:

1. Age 0 day to 14 year-old

2. Diagnosis of tachycardia (paroxysmal supraventricular tachycardia, paroxysmal atrial tachycardia, ventricular tachycardia, idiopathic ventricular tachycardia, premature ventricular contraction) and had an episode within 3 months; Premature Ventricular Contractions (PVC) (total 10000 times/d, or>5000 times/d with multiple source PVC, or total > 3000 times/d but with paired PVC+ multiple source PVC, or ventricular tachycardia);

3. Although PVC= 10000 times/d, but there are obvious symptoms such as palpitation, chest tightness, fatigue, dizziness and other symptoms that need improvement.

4. Signed informed consent before the trial

5. Good compliance

Exclusion Criteria:

1. Heart failure that is ineffective in conventional treatment;

2. Left ventricular ejection fraction (LVEF) = 50%;

3. Suffering from bronchial asthma;

4. Resting sinus heart rate (HR) in newborns <90 bpm; -8 yrs <80 bpm; = 8 yrs <60 bpm;

5. Corrected QT Interval (QTc) = 450ms;

6. II ° -III ° atrioventricular block (AVB);

7. Severe liver, renal dysfunction, acute myocardial infarction, acute myocarditis, electrolyte imbalance have not been corrected;

8. The child has undergone major surgery in the past 4 weeks;

9. The child has participated in other clinical trials in the past 4 weeks;

10. The child has digestive, nervous, circulatory, kidney or liver disease

Related Conditions & MeSH terms

• Arrhythmia
• Ventricular Premature Complexes

Intervention

Drug:
• sotalol
Oral sotalol 2.5mg/kg/time, per 12h
• Propafenone
Oral Propafenone 5mg/kg/time, pre 8h
• betaloc
Oral betaloc 0.5mg/kg/time ,pre 12h

Locations

Country	Name	City	State
China	Shenjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QT interval of ECG		1 week
Primary	QT interval of ECG		3 month
Secondary	Blood pressure		1 week, 3 month
Secondary	Red Blood Cell (RBC)	The indicator is obtained through blood routine.	1 week, 3 month
Secondary	Wed Blood Cell (WBC)	The indicator is obtained through blood routine.	1 week, 3 month
Secondary	Hemoglobin	The indicator is obtained through blood routine.	1 week, 3 month
Secondary	Platelet	The indicator is obtained through blood routine.	1 week, 3 month
Secondary	Albumin	The indicator is obtained through liver function test.	1 week, 3 month
Secondary	Alanine aminotransferase (ALT)	The indicator is obtained through liver function test.	1 week, 3 month
Secondary	Aspertate aminotransferase (AST)	The indicator is obtained through liver function test.	1 week, 3 month
Secondary	Creatinine	The indicator is obtained through kidney function test.	1 week, 3 month